1. Field of the Invention
The present invention relates to a method of gastrostomy, and an infection preventive cover, kit or catheter kit and a gastrostomy catheter kit for use with the method.
2. Description of the Related Art
For a percutaneous endoscopic gastrostomy (PEG) enabling enteral feeding of a patient who finds swallowing food difficulty or who cannot swallow, it is sufficient to apply a local anethesia to the patient and the operation time is favorably short, i.e., about five to about ten minutes, and the patient can quickly recover after the operation. In a case where the patient in a good general condition after the operation, she or he may leave the hospital on the same day on which the operation is conducted. The PEG and its use has therefore developed rapidly worldwide. In the United States, for example, about 180,000 cases were reported in 1997. In the future, the number of the operations is in the world is expected to increase.
As commonly known, the PEG includes three methods, namely, xe2x80x9cpullxe2x80x9d, xe2x80x9cpushxe2x80x9d, and xe2x80x9cintroducerxe2x80x9d methods (techniques). Among these methods, the xe2x80x9cpullxe2x80x9d and xe2x80x9cpushxe2x80x9d methods have been broadly adopted due to simplicity and safety of the operation. However, these methods include the drawbacks described below.
The endoscope is required to be twice inserted in the pertinent patient, which leads to a problem of complex operations and pain to patients. There exists a fear of damage to the larynx, the upper pharynx or the esophagus.
The PEG catheter (including a PEG tube and a dome connected to the tube) is infected in the oral cavity, the upper pharynx or the larynx and hence the wounded part of the patient is liable to be infected.
The first drawback above can be overcome by improving the sedation or anesthesia and by increasing the quality of skill of the endoscopist. However, the second drawback, i.e., the infection of the wound due to the contamination of the PEG tube and the dome has a high possibility of occupancy. The literature from Europe and America reported about 35% to about 45% of the infection of wound. When the infection of a wound occurs, antibiotics are required to be administered to the patient for a long period of time. This resultantly delays the starting point of the enteral feeding for the patient, and the immunity of the patient from diseases is weakened, this may lengthen the hospital treatment in some cases. The patient suffers from serious pains and the fee for medical treatment soars. Consequently, not only the patient but also family members of the patient must bear the expense and suffer from mental stress. When the cleaning of the oral cavity, the preoperation disinfection of the upper pharynx, and the preventive administration of antibiotics are completely carried out, the number of bacteria appearing on the PEG tube and the dome can be decreased. However, this is not the basic countermeasure.
It is therefore an object of the present invention to provide a method of gastrostomy capable of preventing the infection of a wound.
Another object of the present invention is to provide an infection preventive cover to prevent the infection of a wound in the method of gastrostomy.
Still another object of the present invention is to provide a gastrostomy catheter (PEG catheter) kit to prevent the infection of a wound in the method of gastrostomy.
Still another object of the present invention is to provide an infection preventive kit to prevent the infection of a wound in the method of gastrostomy.
Yet another object of the present invention is to provide an infection preventive catheter kit to prevent the infection of a wound in the method of gastrostomy.
Further another object of the present invention is to provide a gastrostomy catheter (PEG catheter) used in the method of gastrostomy which exhibits fine performance.
A method of gastrostomy in accordance with the present invention includes inserting a guide wire into a stomach through an outer tube pierced through a wall of an abdomen and a wall of the stomach of a patient and pulling the guide wire through an esophagus and an oral cavity into a space outside the patient, joining one end of a percutaneous endoscopic gastrostomy (PEG) catheter with the guide wire, delivering the PEG catheter into the stomach by pulling (xe2x80x9cpulling methodxe2x80x9d) or pushing (xe2x80x9cpushing methodxe2x80x9d) the guide wire, drawing the PEG catheter together with the outer tube through a hole in the wall of the stomach and the abdomen wall into a space outside the patient, keeping another end of the PEG catheter in the stomach (including a case in which the end is cut away from the catheter), characterized by enclosing entirely the PEG catheter with an infection preventive cover having a sheath, the sheath having one opening end, closing the opening end of the sheath in the vicinity of the position of a joint between the PEG catheter and the guide wire, delivering the PEG catheter through the oral cavity into the stomach with the PEG catheter covered with the infection preventive cover, opening the opening end of the sheath in the stomach, drawing the PEG catheter into a space outside the patient, while drawing the PEG catheter through the opening end of the sheath opened, and removing thereafter the infection preventive cover from the oral cavity into a space outside the patient. The present invention is applicable to either the xe2x80x9cpush methodxe2x80x9d or the xe2x80x9cpush methodxe2x80x9d of gastrostomy.
In accordance with the present invention, the PEG catheter and the joint section between the PEG catheter and the guide wire are covered outside the oral cavity with the infection preventive cover having a sheath to be delivered from the oral cavity into the stomach in the covered state. Since the opening end of the infection preventive cover is closed until the cover reaches the stomach, the PEG catheter does not directly contact the oral cavity, the larynx and the upper pharynx of the patient. The PEG catheter is therefore kept clean.
The opening end of the infection preventive cover is opened in the stomach of the patient, and the PEG catheter is withdrawn through the opening end of the cover and is drawn through a hole (wounded part of the patient) prepared in the abdominal and stomach walls into a space outside the patient. When the PEG catheter is delivered into the stomach, the catheter is kept clean, namely, is not inflected. Even when the clean PEG catheter is brought into contact with the hole (wound) in the abdominal and stomach walls, the hole (wound) is hardly inflected. Consequently, infection of the wound can be efficiently prevented.
An infection preventive cover in accordance with the present invention is used in the gastrostomy and comprises an elongated sheath having at least one opening end, a binding thread embroidered along a circumferential edge of the opening end of the sheath, and a cutting thread linked to the binding thread, the both ends of the binding thread being led outside the sheath at positions near to each other, and the cutting thread being stronger than the binding thread.
There can be considered various kinds of embroidering of the binding thread (a ligature) in the opening end of the sheath. For example, the ligature is reciprocally embroidered with an appropriate interval between an inner side and an outer side of the opening end portion of the sheath. Alternatively, the opening end portion of the sheath is folded back and the folded-back edge is fixed to the sheath by welding, melting or the like to thereby produce a threading bag, pass or guide, and the ligature is passed through the threading bag.
The cutting thread also includes a thread made of metal such as a metallic wire. Any chemical fiber such as nylon may be used if the cutting thread is stronger than the ligature. The sentence xe2x80x9ca cutting thread is linked to the binding threadxe2x80x9d includes a state in which the cutting thread is doubled to simply engage with the ligature.
For the infection preventive cover (the sheath), there is favorably employed thin, airtight, waterproof, flexible and strong materials such as vinyl and rubber. The PEG catheter may be covered with the infection preventive cover by inserting the PEG catheter into the elongated sheath.
Since the ligature is provided beforehand in the sheath, the operator need only bind the ligature to close the opening end of the sheath. Another method may also be adopted by use of the ligature to close the opening end. The operator need not be skillful with fingers to attach the sheath, and the gastrostomy can be hence completed in a short period of time.
The PEG catheter is entirely covered with the sheath of the infection preventive cover in accordance with the present invention. Consequently, the infection of the wound can be prevented in the gastrostomy. The cutting thread can be drawn through the outer tube punctured into the abdomen wall or through the sheath into a space outside the patient. Consequently, by drawing the cutting thread to cut the ligature, it is possible to open the opening end of the sheath in the stomach.
An infection preventive cover kit in accordance with the present invention, includes an elongated sheath having at least one opening end, a binding thread (a ligature) to close the opening end of the sheath, and a cutting thread linked to the binding thread, the cutting thread being stronger than the binding thread.
The binding thread (a ligature) may be attached onto the sheath or may be separated therefrom. In either case, the opening end of the sheath covering the PEG catheter can be bound by the ligature into a closed state thereof. In the stomach, the ligature is cut by the cutting thread to thereby open the opening end of the sheath.
The present invention provides a PEG catheter kit utilizing the above infection preventive cover or the infection preventive cover kit. The PEG catheter kit comprises a PEG catheter, a sheath, into which the PEG catheter has been inserted, having at least one opening end, a binding thread to close the opening end of the sheath, and a cutting thread linked to the binding thread, the cutting thread being stronger than the binding thread. Since the PEG catheter has been covered with the sheath, a work for covering the PEG catheter with the sheath can be dispensed with. This also minimizes the period of time necessary for the gastrostomy. The opening end of the sheath covering the PEG catheter can be bound by the binding thread into a closed state thereof. By drawing the cutting thread, the binding thread is cut by the cutting thread to thereby open the opening end of the sheath in the stomach.
In one embodiment, the binding thread is embroidered along a circumferential edge of the opening end of the sheath, and the both ends of the binding thread are led outside the sheath at positions near to each other.
A PEG catheter kit in accordance with the present invention includes a PEG catheter, an elongated sheath entirety enclosing the PEG catheter, a fixing device integrally provided to an end of the sheath, an end of the PEG catheter being arranged at the fixing device, and a breaking thread for breaking a portion of the fixing device and a portion of the sheath. Since the PEG catheter has been covered with the sheath, a work for covering the PEG catheter with the sheath can be dispensed with. This also minimizes the period of time necessary for the gastrostomy. Moreover, it may also be possible that the breaking thread is drawn through an outer tube pierced through the abdomen wall or through the sheath into a space outside the patient such that at least the fixing device (and favorably, a part of the sheath) is broken or cut away by the breaking thread in the stomach to open the opening end of the sheath so as to withdraw the PEG catheter out of the sheath.
Another PEG catheter kit in accordance with the present invention includes a PEG catheter, a sheath substantially enclosing the PEG catheter, an end of the sheath being closed, and a breaking thread, an end portion of which is fixed to the closed end portion of the sheath, for breaking the closed end portion of the sheath when the other end of the breaking thread is pulled. Since the PEG catheter has been covered with the sheath, a work for covering the PEG catheter with the sheath can be dispensed with. Moreover, it may also be possible that the breaking thread is drawn through an outer tube pierced through the abdomen wall or through the sheath into a space outside the patient such that a part of the sheath is cut away by the breaking thread in the stomach to open the opening end of the sheath so as to withdraw the PEG catheter out of the sheath.
In one embodiment, the catheter includes a joint wire extending from a top of the catheter, and the end of the sheath closes at a position of the joint wire. Preferably, a part of the joint wire which is exposed outside of the sheath is sufficiently disinfected before use.
An infection preventive cover according to the present invention includes a sheath having at least one opening end, a closing thread embroidered along a circumferential edge of the opening end of the sheath, and a tube for tightening. Two portions of the closing thread having ends are apart from the embroidered portion thereof at positions near to each other. The tightening tube is disposed such that one end of the tube is in the vicinity of the embroidered portion. At least one portion of the closing thread is inserted into the one end of the tightening tube and passes loosely through inside of the tightening tube to be led outside from the other end of the tightening tube.
There can be considered various kinds of embroidering of the closing thread in the opening end of the sheath. For example, the opening end portion of the sheath is folded back and the folded back edge is fixed to the sheath by welding, melting or like to thereby produce a threading bag, pass or guide, and the closing thread is passed through the threading bag. Alternatively, the closing thread is reciprocally embroidered with an appropriate interval between an inner side and an outer side of the opening end portion of the sheath. The closing thread may be turned back on the circumferential edge of the opening end of the sheath, that is, the closing thread is formed to be a loop along the opening end of the sheath, and the two portions having ends may be passed through the tightening tube to be led outside of the tightening tube. Alternatively, the closing thread may be turned back on the circumferential edge of the opening end of the sheath, an end of a portion of the closing thread may be fixed to the one end of the tightening tube, and the other portion of the closing thread having the other end may be passed through the tightening tube to be led outside. Further the closing thread may be turned back on the circumferential edge of the opening end of the sheath, an end of a portion of the closing thread my be fixed to a ring, and the other portion of the closing thread having the other end may be passed through the ring and further through the tightening tube to be led outside.
Preferably, the tightening tube extends along the sheath in the longitudinal direction thereof. The tightening tube may be disposed along inside of the sheath or along outside of the sheath. The sheath may be provided with a cover and the tightening tube extending along the longitudinal direction of the sheath is covered with the cover except for at least the other end of the tightening tube. The cover may be welded, meted or adhered to be fixed to the sheath at both sides thereof, so that a bag, pass or guide is formed by the cover and the sheath, into which the tightening tube is inserted. The cover itself may be a bag.
The sheath is longer than the distance from the stomach to mouth of a patient and has an enough length to entirely cover a percutaneous endoscopic gastrostomy catheter (PEG catheter). The tightening tube may be shorter than the sheath, and is sufficient to have the length from the stomach to mouth of the patient.
For the infection preventive cover (the sheath), there is favorably employed thin, airtight, waterproof, flexible and strong materials such as vinyl and rubber. The PEG catheter may be covered with the infection preventive cover by inserting the PEG catheter into the elongated sheath.
For the closing thread, materials such as silk, linen, cotton, polyester, polyethylene and any other vegetable fiber, chemical fiber or metal materials may be used.
The infection preventive cover in accordance with the present invention is used in a method of gastrostomy as follows;
In the method of gastrostomy a guide wire is inserted into a stomach through an outer tube pierced through a wall of an abdomen and a wall of the stomach of a patient. The guide wire is pulled through an esophagus and an oral cavity into a space outside the patient. One end (a conical top portion) of a percutaneous endoscopic gastrostomy (PEG) catheter is joined with the guide wire. The PEG catheter is delivered from the mouth into the stomach of the patient by pulling (xe2x80x9cpulling methodxe2x80x9d) or pushing (xe2x80x9cpushing methodxe2x80x9d) the guide wire.
Prior to the delivery of the PEG catheter into the stomach from the mouth of the patient, the PEG catheter is entirely enclosed with the infection preventive cover including the long sheath having at least one opening end, and the opening end of the sheath is closed in the vicinity of the position of a joint between the PEG catheter and the guide wire. The PEG catheter may be inserted into the sheath when the infection preventive cover is manufactured, or alternatively the PEG catheter may be inserted into the sheath in the performance of an operation.
The PEG catheter is delivered through the oral cavity into the stomach with the PEG catheter covered with the infection preventive cover, and the opening end of the sheath is opened in the stomach. The PEG catheter is drawn through the stomach wall and the abdomen wall into a space outside the patient together with the outer tube, while the PEG catheter is drawn through the opening end of the sheath opened. Thereafter the infection preventive cover is removed from the oral cavity into a space outside the patient. The distal end portion of the PEG catheter is left in the stomach (inclusive of a case where the distal end portion is cut off from the catheter).
In accordance with the present invention, the PEG catheter (and, in some cases, the joint section between the PEG catheter and the guide wire in dependence upon the construction of the PEG catheter) is covered outside the oral cavity with the infection preventive cover having a sheath to be delivered from the oral cavity into the stomach in the covered state. Since the opening end of the infection preventive cover is closed until the cover reaches the stomach, the PEG catheter does not directly brought into contact with the oral cavity, the larynx and the upper pharynx of the patient. The PEG catheter is therefore kept clean.
The opening end of the infection preventive cover is opened in the stomach of the patient, and the PEG catheter is withdrawn through the opening end of the cover and is drawn through a hole (wounded part of the patient) prepared in the abdominal and stomach walls into a space outside the patient. When the PEG catheter is delivered into the stomach, the catheter is kept clean, namely, is not inflected. Even when the clean PEG catheter is brought into contact with the hole (wound) in the abdominal and stomach walls, the hole (wound) is hardly inflected. Consequently, infection of the wound can be efficiently prevented.
In accordance with the present invention, the closing thread is embroidered along the circumferential edge of the opening end of the sheath in advance. The closing thread is inserted into the one end of the tightening tube, passed through the tightening tube and drawn into outside from the other end of the tightening tube. If the portion of the closing thread which is led outside from the other end of the tightening tube is pulled and the tightening tube is pushed until the one end of the tightening tube abuts against the embroidered portion, the opening end is fastened or tightened by the closing thread passing through the embroidered portion and the opening end is closed. The opening end of the sheath is kept in the closed state, when the closing thread is kept or held or maintained in the strained or tensed state, for example, by a clamping member. If the strained closingxe2x80x94thread is loosened, for example, the clamping member is removed or unfastened, the opening end of the sheath is naturally opened (due to the elasticity of the sheath) or becomes openable state. The operator need not be skillful with fingers to close the opening end of the sheath and to re-open the closed opening-end. The gastrostomy can be hence completed in a short period of time.
An infection preventive kit in accordance with the present invention includes a sheath having at least one opening end, a closing thread embroidered along a circumferential edge of the opening end of the sheath, a tube for tightening through which the closing thread is loosely passed, and a clamping member for keeping the opening end of the sheath being closed by the closing thread. The infection preventive kit is a combination of the sheath, the closing thread, the tightening tube and the clamping member, and is provided or supplied as the combination. Accordingly, the operator has only to cover the PEG catheter with the infection preventive cover, i.e., to insert the PEG catheter into the sheath before or in the operation of gastrostomy.
Preferably, the tightening tube is provided or supplied in the state that the tube is covered with a cover (the tube is inserted between the cover and the sheath).
The infection preventive kit is used in a method of gastrostomy in the same way as described above to prevent infection of the wound. It is possible to make it easy to open or close the opening end of the sheath by pulling the closing thread with respect to the tightening tube or loosening the strained state of the closing thread.
In one embodiment of the present invention, the clamping member is an elastic member which the portion of the closing thread led outside the tightening tube penetrates. When the closing thread is pulled in order to close the opening end of the sheath, and the clamping member is moved to a position where the clamping member abuts against the other end of the tightening tube, the closing thread cannot move any more by a frictional force between the closing thread and the elastic member and held in the strained state. The other members than the elastic member can be used as the clamping member, for example, a member having a slit formed thereon to sandwich the closing thread between portions of the member existing both sides of the slit, or clips.
The present invention further provides an infection preventive catheter kit including the infection preventive cover or the infection preventive kit. The infection preventive catheter kit comprises a percutaneous endossopic gastrostomy (PEG) catheter, a sheath, into which the PEG catheter has been inserted, having at least one opening end, a closing thread embroidered along a circumferential edge of the opening end of the sheath, a tightening tube inside of which the closing thread loosely passes through, and a clamping member for keeping a state in which the opening end of the sheath is closed by the closing thread.
Since the PEG catheter has been covered with the sheath, a work for covering the PEG catheter with the sheath can be dispensed with. The gastrostomy operation can be completed in a short period of time. Using the closing thread and the tightening tube, the opening end of the sheath can be closed and can be opened in the stomach.
The present invention further provides a percutaneous endoscopic gastrostomy (PEG) catheter, which has a top portion of conical shaped. The conical top portion is hollow and has an opening formed thereon at the top end thereof. The opening has such size that an engaging head formed at a top end of a guide wire passes therethrough, and the inside of the conical hollow top portion is larger than the opening in diameter. The hollow conical top portion is provided with an engaging piece on the inside thereof, the engaging piece allowing the bead of the guide wire which is inserted into the opening to pass therethrough and preventing the head from being pulled out.
The transversal section of the inside of the conical hollow top portion and the top opening are not limited to a circle. In a case where the transversal section of the hollow inside of the conical top portion is rectangle or other shapes, the expression that the inside of the conical hollow top portion is larger than the opening in diameter means that a side or a diagonal of the transversal section of the hollow inside of the conical top portion is larger or longer than the diameter, side or diagonal of the top opening.
There are following merits in using the above PEG catheter of the present invention. When the guide wire which is pulled through an esophagus and an oral cavity into a space outside the patient is joined with the top portion of the PEG catheter in the method of gastrostomy, the operator has only to insert the top end (head) of the guide wire into the opening formed on the conical top portion. The head formed on the top end of the guide wire enters into the hollow inside of the top portion through the top opening. The guide wire and the head are prevented from being pulled out by the engaging piece. Thus the guide wire is joined with the conical top portion of the PEG catheter. Accordingly, work for joining the guide wire with the PEG catheter is easy and time required for gastrostomy is shortened. In one embodiment, the engaging piece is disposed inside of the conical hollow top portion obliquely with respect to an axial direction of the conical hollow top portion, and the engaging piece is formed with a first slit for passing having a width larger than the head of the guide wire at an end portion of the piece which is directed to the guide wire insertion direction and a second slit for pull-out prevention having a width smaller than the head of the guide wire and being coupled with the first slit.
As described above, the first wide slit for passing which is formed on the engaging piece provided in hollow inside of the conical top portion of the PEG catheter allows the head formed on the top end of the guide wire to pass therethrough. When the guide wire is inserted into the hollow inside of the conical top portion through the top opening, the inserted head of the guide wire proceeds to through the first slit of the engaging piece (beyond the engaging piece). The guide wire portion (exclusive of the head) enters (falls down) into the narrow slit for pull-out prevention which is connected to or coupled with the wide first slit. Since the second slit is narrower than the top head of the guide wire in width, the top head is prevented from being pulled out (moving) even if the guide wire is pulled toward outside. The guide wire and the PEG catheter can be easily joined or linked and time required for gastrostomy is shortened.